BioLabs' radiation drug on fast track

A drug developed in Buffalo to treat Acute Radiation Syndrome has been granted Fast Track status by the U.S. Food and Drug Administration.

CBLB502 was developed by Cleveland BioLabs Inc. (NASDAQ:CBLI). It is injected into muscle tissue to treat Acute Radiation Syndrome or radiation poisoning from exposure to radiation such as that from a nuclear or radiological weapon, or from a nuclear accident.

The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need.

Fast Track designations allow companies to file a New Drug Application or Biologics License Application and permits the Food and Drug Administration to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process.

Additionally, both applications for fast track development programs are eligible for priority review. This may result in an abbreviated review time of six months, which can expedite getting the drug to market.

Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, said the drug is being developed at the Cleveland BioLabs Inc. office at the Buffalo Niagara Medical Campus which employs around 40.

CBLB502 is the first drug to be fast tracked for the seven-year-old company.

Fonstein said clinical development took place in Buffalo and at other locations, and that no existing drugs deal with Acute Radiation Syndrome.

And while traditional drug manufacturers enter partnerships with pharmaceutical companies to go to market, Fonstein said this would not be the case with CBLB502.

“Our situation is different, as our targeted customer is federal agencies of the U.S. and other countries, so it will sell itself,” he said.

“We already have support to the tune of hundreds of millions of dollars, buyers being the Department of Health and Human Services, and the Dept of Defense.